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Search / Trial NCT05665764

The Feasibility of Home-Based Measurement of Circadian Timing for Veterans With TBI and Insomnia

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Dec 16, 2022

Trial Information

Current as of June 26, 2025

Enrolling by invitation

Keywords

Circadian Phase Veteran Traumatic Brain Injury Insomnia

ClinConnect Summary

Background and Significance:

Insomnia is a pervasive problem among Veterans with traumatic brain injury (TBI). Veterans with TBI frequently experience sleep disturbances following their injury. Insomnia, an impairing disorder characterized by difficulty initiating or maintaining sleep, is the most common sleep disturbance reported following TBI. Indeed, Veterans with TBI are 50% more likely to develop future insomnia compared to their non-injured peers.

The development of insomnia following TBI can delay recovery and contribute to functional impairments. Compared to TBI patients with norm...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Veterans
  • History of traumatic brain injury
  • Current insomnia
  • Exclusion Criteria:
  • Alcohol or substance abuse in the past 12 months
  • History of psychotic or bipolar disorders
  • Currently using of beta-blockers or melatonin-related substances (including over-the-counter or herbal products)
  • Currently participating in a sleep-targeted psychotherapy
  • Transmeridian travel (i.e., change in at least 2 time zones) in the past month
  • Shift work (i.e., at least 6 hours between 10 pm and 8 am) in the past 6 months
  • Currently pregnant or lactating
  • Current untreated sleep apnea
  • Lack of access to a home freezer
  • Blindness
  • Inability to independently provide informed consent

About Va Office Of Research And Development

The VA Office of Research and Development (ORD) is dedicated to advancing the health and well-being of veterans through innovative research initiatives. As a pivotal sponsor of clinical trials, ORD focuses on a broad spectrum of health-related topics, including mental health, rehabilitation, and chronic disease management, ensuring that findings are directly applicable to the unique needs of the veteran population. With a commitment to scientific excellence and collaboration, ORD promotes rigorous study designs and ethical standards, facilitating the translation of research discoveries into improved clinical practices and policies that enhance veteran care.

Locations

Aurora, Colorado, United States

Aurora, Colorado, United States

Patients applied

0 patients applied

Trial Officials

Daniel J Reis, PhD

Principal Investigator

Rocky Mountain Regional VA Medical Center, Aurora, CO

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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